Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

NCT ID: NCT02715947

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-12-31

Brief Summary

To investigate the influence of genetic factors on the curative effect , to find the relationships between genetic variants and the response of Methotrexate to treatment of Psoriasis Vulgaris.

Detailed Description

Previous studies have indicated that the gene mutations of absorption distribution metabolism and drug target may affect the efficacy of Methotrexate in vivo.To investigate the influence of genetic factors on the curative effect , to find the relationships between genetic variants and the response of Methotrexate to treatment of Psoriasis Vulgaris.Investigators analyzed the various levels of genetic factors, including: 1.To analysis the key gene variants which associated with ADME(absorption, distribution, metabolism and excretion) affect the efficacy of Methotrexate; 2.Direct full genetic sequencing of MHC genes, to explore the genetic variations of efficacy and side effects; 3. Direct sequencing of all exons in the gene in the patients of the response of serious and effectively, to explores the rare genetic variation may cause deterioration of treatment by Methotrexate.

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single-arm

intervention: open registry, non-randomized, single-arm trial.Methotrexate:2.5mg per piece, oral.

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

During The first week: 7.5mg per week, oral; The second and third weeks: 10mg per week, oral; The fourth and fifth weeks: 12.5mg per week,oral; The sixth week:15mg per week, and maintain this dose, oral.

Interventions

Methotrexate

During The first week: 7.5mg per week, oral; The second and third weeks: 10mg per week, oral; The fourth and fifth weeks: 12.5mg per week,oral; The sixth week:15mg per week, and maintain this dose, oral.

Intervention Type: DRUG

Other Intervention Names

Amethopterin

Eligibility Criteria

Inclusion Criteria

1. Diagnosed according to Classification criteria for Psoriasis vulgaris

2. Patients aged 18 to 70 years (to the date of screening)

3. Not treatment in the Topical corticosteroids, Biologicals agents or Tretinoin cream

4. Phototherapy nearly one months before enrolled

5. Total bilirubin < 1.5 x ULN, AST(SGOT)/ALT(SGPT) <2.5 x ULN, if not liver metastases < 5 x ULN, if known liver metastases, Creatinine clearance <1.5 x ULN

6. Understanding the whole process of the study, voluntary participation and signed the informed consent

Exclusion Criteria

1. Pregnant women, ready to pregnant or lactating women

2. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history

3. Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers

4. Patients with chronic diarrhea, or peptic ulcer nearly 1 year

5. Patients suffering from malignant tumor

6. Patients suffering from acute and chronic infectious diseases

7. Mental disorders, history of alcohol abuse, drug or other substance abuse

8. Other cases which researchers believe that can not enroll

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Yijing He

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Locations

Xiangya Hospital Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yijing He, MD,PhD

Role: CONTACT

yijinghe@gmail.com

+86-1587481262

Facility Contacts

Yijing He, MD, PhD

Role: primary

yijinghe@gmail.com

+86-1587481262

Other Identifiers

2016 MTX/CSU/PS

Identifier Type: -

Identifier Source: org_study_id